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What is a IEC 60601-1-11 home healthcare power supply?

The FDA defines a home use medical device as “a device intended for users in a non-clinical or transitory environment, which is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a healthcare professional in order to be used safely and effectively. This includes permanently and temporarily implanted devices and any type of equipment that a person may use to recover and rehabilitate.” 

IEC 60601-1-11 is the current version of collateral standard IEC 60601-1 that applies to the basic safety and essential performance of medical electrical equipment used in home settings. Effective June 30, 2013 in the European Union and December 31, 2013 in the U.S., the new standard differs from the previous edition(s) in several key ways. It now requires a ‘Class II’ electrical categorization of medical equipment, an elevated ingress protection (IP), and systems for home use and expands the definition of the ‘home environment’ to include European nursing homes. 


a IEC 60601-1-11 home healthcare power supply is an AC to DC converter which complies with the standards specified in IEC 60601-1-11. aside from the basic requirements for medical power supplies such as elevated dielectric with stand voltage and low leakage current home health care power packs also require to be Class II and a minimum ingress protection level of IP21. IEC 60601-1-11 is also listed inside of the product CB, UL, and other regulatory reports.


How do I know if I need an IEC 60601-1-11 home healthcare power supply adapter?

The final use application and where that device would be used would dictate if it's necessary to comply with IEC 60601-1-11 . 

Are there any restrictions as to the type of power supply that could qualify as IEC 60601-1-11 ?

Most types of GlobTek medical power supplies and AC to dc adapters qualify as IEC 60601-1-11. GlobTek offers both external desktop or wall plug-in power supplies that meet the standard. The main constraints for the AC to DC adapters to meet IEC 60601-1-11 are that they are class II and have an elevated ingress protection level.  What is an IEC 60601-1 medical grade rated power supply AC adapter?

An IEC 60601-1-2 medical grade rated power supply AC adapter converts input line voltage from the wall to a lower voltage, typically DC, which is used to operate and end use piece of medical equipment. IEC 60601-1-2 medical grade power supply AC adapters are typically housed in a plastic enclosure and are available with both 2 and 3 prong input options. power supplies are also available as open frame for use inside of medical equipment. These AC to DC converters are designed in accordance with international medical standards and provide for compliance with certain aspects of them which differs from generic information and communication technology equipment power supplies.

Why is my medical grade IEC 60601-1 power supply certified to IEC 60601-1 3rd Edition while the latest standard is IEC 60601-1 4th Edition?
IEC 60601-1 has different sections in specifications for safety and EMI/EMC. The latest revision of the safety portion of  IEC 60601-1 is 3rd Edition while for EMI/EMC the latest revision is 60601-1-2, 4th Ed. 

What is the effective date of 60601-1-2, 4th Ed?
60601-1-2, 4th Ed. was effective on December 31, 2018.

What's the difference between an IEC 60950-1 and IEC 60601-1 medical grade rated power supply?

IEC 60950-1 and IEC 60601-1-2 power supplies are both AC to DC converters and may be either internal or external but are designed to different specifications to match the end system specifications. While the basic performance behaviors are similar such as input and output voltages and mechanical configurations, there are many differences as well. Some of the key differences are that medical IEC 60601 medical grade AC to DC adapters are able to withstand a higher dielectric withstand voltage and must have lower leakage current.  There are many other differences and also considerations to consider depending on the end use application.  

What MOOP and MOPP?
Medical devices must incorporate one or more Means of Protection (MOPs) to isolate patients and operators from the risks of electrocution. A Means of Protection (MOPs)  can be safety insulation, a protective earth, a defined creepage distance, or an air gap or other protective impedance. These can be used in various combinations. IEC 60601-1 3rd edition differentiates between the risk to patients and the risk to operators. A MOP can therefore be classified as Means of Patient Protection (MOPP) or a Means of Operator Protection (MOOP). The main difference between one MOOP and one MOPP is primarily one of permissible creepage distance. Both requirements are satisfied using Basic insulation. To achieve 2 x MOPP qualification the isolation test is particularly demanding at 4000 Vac and the creepage distance of 8mm is twice that required for one MOPP. 

What is a BF and CF rated an IEC 60601-1-2 medical grade rated power supply AC adapter and what is the difference?

Medical grade power supplies and AC to DC adapters are categorized into one of three applied parts types: body type (B), body floating type (BF), and cardiac floating type (CF). These applied parts require specific attributes such as isolation voltage, creepage and leakage current. Floating refers to an ungrounded power supply, Class II, that is not referenced to another output and is fully isolated. Type B refers to devices that operate within the patient's vicinity, as described in IEC 60601-1 as six feet around a patient's chair or bed and do not touch the patient electronically and are grounded. These devices include operating room lighting, hospital carts and beds, automated dispensers of medication and supplies, and diagnostic equipment like x-ray machines. Type BF devices deliver electrical energy signals to or from the patient such as electrosurgical devices, endoscopes, and electrical vital sign monitors like thermometers. Type CF devices are similar to BF, except they supply power to devices connected to the heart, such as a defibrillator, external pacemaker or intracardiac ECG electrodes and Type CF requires a higher degree of protection against electrical shock than BF types.  
 

What is a IEC 62368-1:2018 power supply?

IEC 62368-1:2018 is applicable to the safety of electrical and electronic equipment within the field of audio, video, information and communication technology, and business and office machines with a rated voltage not exceeding 600 V. This is a product safety standard that classifies energy sources, prescribes safeguards against those energy sources, and provides guidance on the application of, and requirements for, those safeguards. The prescribed safeguards are intended to reduce the likelihood of pain, injury and, in the case of fire, property damage. An IEC 62368-1 rated AC to DC converter or power supply is a power supply that has been tested to and certified to comply with the said standard.

Did IEC 62368-1 power supplies replace IEC60950-1 power supplies?

On December 20, 2020 the safety standards that historically have applied to information technology equipment and audio video equipment, IEC 60065 and IEC 60950-1,transition to IEC 62368-1. In North America ETL and UL 60950-1 certifications will continue to stay valid and may continue to be used until further notice. 

What is the difference between an IEC 62368-1 and a IEC 60950-1 power supply?

While the structure and contents of the standards are very different in general most products that previously complied with IEC 60950-1 comply with the latest standard IEC 62368-1 with little or no modification.

Will my IEC60950-1 power supply remain available?

GlobTek will continue to manufacture and supply IEC 60950-1 power supplies indefinitely until further notice.

What is Level VI Efficiency?

The numerals I to VI are an International Efficiency Marking Protocol which allows manufacturers to designate the efficiency performance of a product. This performance is based on the measurement of the operating energy efficiency and no-load power consumption of external power supplies or AC DC adapters tested at different load levels. The no-load power consumption refers to the amount of power that an external power supply draws even when the application is turned off or disconnected.

Is Level VI Efficiency required?

Level VI efficiency is mandated in certain countries and regions for certain products or certain applications.

What is the Eco-design Directive 2009/125/EC?

The Eco-design directive put into law in Europe the latest requirements for energy efficiency and conservation for AC DC adapters and external power supplies.

What is the The Unique Device Identification (UDI) for my GlobTek medical grade power supply?

The Unique Device Identification (UDI) as required by the Food and Drug Administration Amendments Act of 2007 and EU Medical Device Regulation (MDR) is required for registered medical devices. While GlobTek medical grade power supplies carry full medical certifications they're actually not considered medical devices themselves but a component of such. And therefore do not have registration with the Food and Drug Administration Amendments Act of 2007 and EU Medical Device Regulation (MDR) and therefore so not carry a The Unique Device Identification (UDI).

How Does an AC-DC Wall Adapter Work?

The AC to DC adapter or external power supply consists of a power supply which is enclosed in a housing similar to an AC plug, hence the term plug type, wall plug in, plug-in or plugtop power adapter. The power supply is plugged into the mains socket and the AC Voltage is then converted by the AC to DC adapter power supply into a DC voltage that is fed into the appliance via the output cable connection.